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Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

Primary Purpose

Disorder Related to Renal Transplantation, Cytomegalovirus Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sirolimus
tacrolimus
mycophenolate
Prednisone
Basiliximab
Thymoglobulin
Sponsored by
Associação Médico Espírita de Botucatu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder Related to Renal Transplantation focused on measuring Kidney transplantation, sirolimus, cytomegalovirus, aged

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Patients aged more than 60 years and recipients of compatible renal transplant

Exclusion Criteria:

  1. Receptors of multiple organs;
  2. non-heart beating donors;
  3. donors aged under 5 or over 65 years;
  4. Patients with body mass index greater than 35

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Tacrolimus + Mycophenolate

    Tacrolimus + Sirolimus

    Arm Description

    The investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 %

    The investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 %

    Outcomes

    Primary Outcome Measures

    Change in estimated glomerular filtration rate from baseline
    The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation. The investigators will be measure the change in eGFR during 12 month follow-up. Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease).

    Secondary Outcome Measures

    Incidence of cytomegalovirus Infection (CMV)
    The secondary end-point will be evaluated the incidence of cytomegalovirus (CMV) infection. CMV infection will be defined based on detection of CMV viral replication (CMV pp65 antigenemia more than zero) in asymptomatic patients. CMV disease will be defined based on the evidence of CMV infection with related symptoms. For the positive cases treatment will be carried out with ganciclovir 5 mg/kg/day twice daily adjusted for renal function for a minimum of 14 days.

    Full Information

    First Posted
    February 5, 2016
    Last Updated
    February 11, 2016
    Sponsor
    Associação Médico Espírita de Botucatu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02683291
    Brief Title
    Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
    Official Title
    Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Associação Médico Espírita de Botucatu

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    There is no consensus on the best immunosuppressive regimen in elderly people. The aim of this study will be to evaluate the efficacy of sirolimus associated with tacrolimus in elderly kidney transplant recipients. The investigators will conduct a single-center prospective randomized study comparing the combination of tacrolimus with sirolimus at reduced dose rate (tacrolimus + sirolimus group) against tacrolimus with mycophenolate (tacrolimus + mycophenolate group). The investigators will include all kidney transplant patients over 60 years of age. The investigators will evaluate estimated glomerular filtration rate and incidence of cytomegalovirus in 12 month follow-up.
    Detailed Description
    Study Design This will be a single-center, prospective, 12-month randomized controlled trial aiming to compare sirolimus associated with tacrolimus in elderly renal transplant patients as to safety and incidence of cytomegalovirus (CMV) infection. Treatments In the control group (Tacrolimus + Mycophenolate) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. In the treatment group (Tacrolimus + sirolimus) the investigators will use tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). In all groups, patients will receive prednisone 30 mg/day (in the first month with weekly reductions up to 5 mg/day at the end of the second month). Induction therapy consisted of basiliximab or antithymocyte globulin (Thymoglobulin, Genzyme®). Thymoglobulin will be used in patients with panel reactivity class I greater than 50 % (at a dose of 1mg/kg for 5 days).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Disorder Related to Renal Transplantation, Cytomegalovirus Infections
    Keywords
    Kidney transplantation, sirolimus, cytomegalovirus, aged

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tacrolimus + Mycophenolate
    Arm Type
    Active Comparator
    Arm Description
    The investigators wil be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8ng/ml at the third month and then 3-7ng/ml from the third month to the 12th month) and mycophenolate sodium 720 mg twice daily. A dose reduction of mycophenolate sodium to 720 mg/day will be accepted due to possible side effects of the drug. Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 %
    Arm Title
    Tacrolimus + Sirolimus
    Arm Type
    Experimental
    Arm Description
    The investigators will be used tacrolimus (starting with 0.1 mg/kg twice daily adjusted to target serum levels by 4-8 ng/ml at the third month and then 3-7 ng/ml from the third month to the 12th month) and sirolimus 2 mg/day (adjusted serum levels at 4-8 ng/ml throughout the study period). Prednisone 30 mg/day in the first month. Induction therapy consisted of basiliximab or thymoglobulin if panel reactivity class I greater than 50 %
    Intervention Type
    Drug
    Intervention Name(s)
    sirolimus
    Other Intervention Name(s)
    Rapamycin, Rapamune
    Intervention Type
    Drug
    Intervention Name(s)
    tacrolimus
    Other Intervention Name(s)
    Prograf, FK506
    Intervention Type
    Drug
    Intervention Name(s)
    mycophenolate
    Other Intervention Name(s)
    Myfortic, Mycophenolate Sodium
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone
    Other Intervention Name(s)
    Meticorten
    Intervention Description
    Prednisone 30mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Basiliximab
    Other Intervention Name(s)
    Simulect
    Intervention Description
    Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
    Intervention Type
    Drug
    Intervention Name(s)
    Thymoglobulin
    Other Intervention Name(s)
    antithymocyte globulin
    Intervention Description
    Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
    Primary Outcome Measure Information:
    Title
    Change in estimated glomerular filtration rate from baseline
    Description
    The primary end-point will be evaluated the estimated glomerular filtration rate (eGFR) over 12 months of renal transplantation. The investigators will be measure the change in eGFR during 12 month follow-up. Glomerular filtration rate will be estimated by the MDRD equation (Modification of Diet in Renal Disease).
    Time Frame
    Baseline, 1 month, 3 months, 6 months and 12 months
    Secondary Outcome Measure Information:
    Title
    Incidence of cytomegalovirus Infection (CMV)
    Description
    The secondary end-point will be evaluated the incidence of cytomegalovirus (CMV) infection. CMV infection will be defined based on detection of CMV viral replication (CMV pp65 antigenemia more than zero) in asymptomatic patients. CMV disease will be defined based on the evidence of CMV infection with related symptoms. For the positive cases treatment will be carried out with ganciclovir 5 mg/kg/day twice daily adjusted for renal function for a minimum of 14 days.
    Time Frame
    Weekly from baseline until the third month. After in 4, 5, 6, 8, 10 and 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Patients aged more than 60 years and recipients of compatible renal transplant Exclusion Criteria: Receptors of multiple organs; non-heart beating donors; donors aged under 5 or over 65 years; Patients with body mass index greater than 35

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

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